A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors

NCT06372574 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: GO44669
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A\*02 eligible patients with locally advanced or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive solid tumors.

Conditions

Refractory Cancer; Recurrent Cancer; Solid Tumor, Adult

Outcome Measures

Primary Outcomes (3)

• Incidence and Severity of Adverse Events

  From first dose until 90 days after the final dose of study treatment (up to approximately 3 years)

• Number of Participants with Abnormal Values in Targeted Vital Signs

  The targeted vital signs include pulse rate, respiratory rate, systolic and diastolic blood pressure, pulse oximetry, and body temperature.

  From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)

• Number of Participants with Abnormal Values in Clinical Laboratory Test Parameters

  From Baseline (predose) until 90 days after the final dose of study treatment (up to approximately 3 years)

Secondary Outcomes (6)

• Serum Concentration of RO7617991 at Specific Timepoints

  From first dose until 30 days after the final dose of study treatment (up to approximately 3 years)

• Objective Response Rate (ORR), as Determined by the Investigator According to RECIST v1.1

  From Baseline until until radiographic disease progression or loss of clinical benefit (up to approximately 3 years)

• Duration of Response (DOR), as Determined by the Investigator According to RECIST v1.1

  From first occurrence of a confirmed objective response to disease progression or death, whichever occurs first (up to approximately 3 years)

• Progression-Free Survival (PFS), as Determined by the Investigator According to RECIST v1.1

  From enrollment to the first occurrence of disease progression or relapse or death, whichever occurs first (up to approximately 3 years)

• Overall Survival (OS)

  From enrollment to death from any cause (up to approximately 3 years)

Study Arms (1)

RO7617991 Dose Escalation and Expansion

EXPERIMENTAL

Drug: RO7617991; Drug: Tocilizumab

Interventions

RO7617991 DRUG

RO7617991 will be administered by intravenous (IV) infusion. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

RO7617991 Dose Escalation and Expansion

Tocilizumab DRUG

Tocilizumab 8 mg/kg IV will be administered to patients when necessary to treat potential cytokine release syndrome (CRS), as described in the protocol.

Also known as: Actemra®, RoActemra®, RO4877533

RO7617991 Dose Escalation and Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Body weight ≥40 kilograms
• Life expectancy of at least 12 weeks
• Confirmed eligible HLA-A\*02 genotype and tumor with confirmed MAGE-A4 expression
• Histologically confirmed locally advanced or metastatic solid tumor malignancy that has relapsed or is refractory to established therapies
• Measurable disease, according to RECIST v1.1
• Adequate hematologic and end-organ function
• Resolution to Grade ≤2 of all acute, clinically significant treatment-related toxicity from prior therapy
• An archival tumor tissue specimen or fresh baseline biopsy (when archival is not available) is required

You may not qualify if:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of RO7617991 or tocilizumab
• Clinically significant cardiopulmonary dysfunction
• Clinically significant liver disease
• Poorly controlled Type 2 diabetes mellitus
• Active hepatitis B or C infection
• Positive test for human immunodeficiency virus (HIV)
• History of allergic reactions to red meat or tick bites or known galactose-alpha-1,3-galactose (alpha-gal) hypersensitivity
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Symptomatic pleural effusion, pericardial effusion, or ascites or any prior procedural intervention for pleural effusion, pericardial effusion, or ascites within 6 weeks prior to enrollment
• Active or history of autoimmune disease or immune deficiency
• Treatment with systemic immunosuppressive medications
• Prior allogeneic stem cell or solid organ transplantation

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Neoplasms; Recurrence

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share